Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI) (NavPed-NI)

September 12, 2016 updated by: Peter C. Rimensberger, University Hospital, Geneva

Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients

The purpose of this study is

  • to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
  • to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
  • and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.

Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.

Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.

One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.

NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.

The 2 sessions, Pressure support and Nava, will be recorded consecutively.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • GE
      • Geneva, GE, Switzerland, 1211
        • University Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation

Exclusion Criteria:

  • Non treated pneumothorax
  • Hemodynamic instability
  • FiO2 > 0.6
  • Poor short term prognosis (defined as a high risk of death in the next seven days)
  • contraindication for gastric tube or obtention of a reliable EMGdi signal
  • Known esophageal problem (hiatal hernia, esophageal varicosities)
  • Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
  • Neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-Invasive Pressure support

in this arm, non-invasive pressure support will be recorded under 3 conditions:

with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15%
Other: Non-invasive Ventilation under Pressure Support

Non-invasive Ventilation under Pressure Support:

15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order

Other Names:
  • NIV-PS/initial settings
  • NIV-PS/ETS-10%
  • NIV-PS/ETS+10%
Active Comparator: NAVA

Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.

The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support
Other: Non-Invasive ventilation under NAVA
20 min session under non-invasive ventilation with NAVA
Other Names:
  • Neurally Adjusted ventilatory Assist
  • Neural ventilation
  • Diaphragmatic electrical activity ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asynchronies
Time Frame: 12 months

Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort.

all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min).

Asynchronies will be determined by measuring each ventilatory cycle of all recordings.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Peter Rimensberger, MD, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUG-matped 09-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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